Pentec Health
Pentec Health appears in FDA public data with 15 recalls, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (D-581-2013, Class II) was initiated on May 15, 2013.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-581-2013 | Class II | Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and steril | May 15, 2013 |
| D-584-2013 | Class II | Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added a | May 15, 2013 |
| D-593-2013 | Class II | Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with a | May 15, 2013 |
| D-588-2013 | Class II | Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids) | May 15, 2013 |
| D-583-2013 | Class II | Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added a | May 15, 2013 |
| D-582-2013 | Class II | Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with add | May 15, 2013 |
| D-595-2013 | Class II | Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added a | May 15, 2013 |
| D-586-2013 | Class II | Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids) | May 15, 2013 |
| D-594-2013 | Class II | Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added | May 15, 2013 |
| D-587-2013 | Class II | Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids) | May 15, 2013 |
| D-592-2013 | Class II | Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acid | May 15, 2013 |
| D-590-2013 | Class II | Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), | May 15, 2013 |
| D-585-2013 | Class II | IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, | May 15, 2013 |
| D-589-2013 | Class II | Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), | May 15, 2013 |
| D-591-2013 | Class II | Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), | May 15, 2013 |